Catalog Number

701052489

Brand Name

Open Heart Pack

Version/Model Number

BEQ-TOP 29400

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 2017

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DWE

Product Code Name

Tubing, Pump, Cardiopulmonary Bypass

Public Device Record Key

7b1f5e3a-a77e-488f-b5d6-2559f0dd7abc

Public Version Date

December 02, 2019

Public Version Number

4

DI Record Publish Date

December 31, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-